Cleared Traditional

STRAIT JACKET (K963463) - FDA 510(k) Clearance

Class I General Hospital device.

K963463 · Deroyal Industries, Inc. · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Oct 1996
Decision
43d
Days
Class 1
Risk

K963463 is an FDA 510(k) clearance for the STRAIT JACKET. Classified as Restraint, Protective (product code FMQ), Class I - General Controls.

Submitted by Deroyal Industries, Inc. (Powell, US). The FDA issued a Cleared decision on October 16, 1996 after a review of 43 days - a notably fast clearance cycle.

This device falls under the General Hospital FDA review panel, regulated under 21 CFR 880.6760 - the FDA general hospital device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Deroyal Industries, Inc. devices

Submission Details

510(k) Number K963463 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 03, 1996
Decision Date October 16, 1996
Days to Decision 43 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
86d faster than avg
Panel avg: 129d · This submission: 43d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code FMQ Restraint, Protective
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 880.6760
What this classification means

Class I devices are subject to general controls only and most are exempt from 510(k) premarket notification. They represent the lowest regulatory burden in the FDA device framework.

Regulatory Peers - FMQ Restraint, Protective

All 11
Devices cleared under the same product code (FMQ) and FDA review panel - the closest regulatory comparables to K963463.
MEDLINE SAETY VEST,MEDLINE ECONOMY VEST, MEDLINE TIE-BACK VEST, MEDLINE SECURTIY VEST, VEST RESTRAINT
K963362 · Medline Industries, Inc. · Oct 1996
MEDLINE PELVIC HOLDER
K963404 · Medline Industries, Inc. · Oct 1996
WHEELCHAIR WAIST BELT, MEDLINE ECONOMY WHEELCHAIR BELT, MEDLINE TWO-PIECE SAFETY SOFT BELT, MEDLINE WHEELCHAIR BELT WITH
K963569 · Medline Industries, Inc. · Oct 1996
SAFETY VEST
K962429 · Johnson & Johnson Professionals, Inc. · Sep 1996
BK-5098 TILT TABLE STRAP
K790172 · Fred Sammons, Inc. · Feb 1979
RESTRAINT, PROTECTIVE
K780232 · Biomet, Inc. · Feb 1978